{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T03:13:30Z","timestamp":1774322010768,"version":"3.50.1"},"reference-count":15,"publisher":"BMJ","issue":"10","license":[{"start":{"date-parts":[[2020,10,9]],"date-time":"2020-10-09T00:00:00Z","timestamp":1602201600000},"content-version":"unspecified","delay-in-days":8,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008196","name":"M\u00e9decins Sans Fronti\u00e8res","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008196","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,9,7]]},"published-print":{"date-parts":[[2020,10]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Current treatment regimens for multidrug-resistant tuberculosis (MDR-TB) are long, poorly tolerated and have poor outcomes. Furthermore, the costs of treating MDR-TB are much greater than those for treating drug-susceptible TB, both for health service and patient-incurred costs. Urgent action is needed to identify short, effective, tolerable and cheaper treatments for people with both quinolone-susceptible and quinolone-resistant MDR-TB. We present the protocol for an economic evaluation (PRACTECAL-EE substudy) alongside an ongoing clinical trial (TB-PRACTECAL) aiming to assess the costs to patients and providers of new regimens, as well as their cost-effectiveness and impact on participant poverty levels. This substudy is based on data from the three countries participating in the main trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>Primary cost data will be collected from the provider and patient perspectives, following economic best practice. We will estimate the probability that new MDR-TB regimens containing bedaquiline, pretomanid and linezolid are cost-effective from a societal perspective as compared with the standard of care for MDR-TB patients in Uzbekistan, South Africa and Belarus. Analysis uses a Markov model populated with primary cost and outcome data collected at each study site. We will also estimate the impact of new regimens on prevalence of catastrophic patient costs due to TB.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval has been obtained from the London School of Hygiene &amp; Tropical Medicine and M\u00e9decins Sans Fronti\u00e8res. Local ethical approval will be sought in each study site. The results of the economic evaluation will be shared with the country health authorities and published in a peer-reviewed journal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov Registry (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT04207112\">NCT04207112<\/jats:ext-link>\n                      ); Pre-results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2019-036599","type":"journal-article","created":{"date-parts":[[2020,10,10]],"date-time":"2020-10-10T13:35:52Z","timestamp":1602336952000},"page":"e036599","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":14,"title":["Cost-effectiveness of new MDR-TB regimens: study protocol for the TB-PRACTECAL economic evaluation substudy"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct04207112","registry":"10.18810\/clinical-trials-gov","type":"preResults"},{"clinical-trial-number":"nct02589782","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4233-9080","authenticated-orcid":false,"given":"Sedona","family":"Sweeney","sequence":"first","affiliation":[{"name":"Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabriela","family":"Gomez","sequence":"additional","affiliation":[{"name":"Vaccine Epidemiology and Modelling, Sanofi Pasteur SA, Lyon, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nichola","family":"Kitson","sequence":"additional","affiliation":[{"name":"Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3213-7813","authenticated-orcid":false,"given":"Animesh","family":"Sinha","sequence":"additional","affiliation":[{"name":"M\u00e9decins Sans Fronti\u00e8res Holland, Minsk, Belarus"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natalia","family":"Yatskevich","sequence":"additional","affiliation":[{"name":"Republican Scientific and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suzanne","family":"Staples","sequence":"additional","affiliation":[{"name":"TB and HIV Investigative Network (THINK), Durban, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ronelle","family":"Moodliar","sequence":"additional","affiliation":[{"name":"TB and HIV Investigative Network (THINK), Durban, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sharon","family":"Motlhako","sequence":"additional","affiliation":[{"name":"Helen Joseph Hospital, Clinical HIV Research Unit, Wits Health Consortium, University of the Witwatersrand, Johannesburg, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matshepo","family":"Maloma","sequence":"additional","affiliation":[{"name":"King DinuZulu Hospital, Clinical HIV Research Unit, Wits Health Consortium, University of the Witwatersrand, Durban, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohammed","family":"Rassool","sequence":"additional","affiliation":[{"name":"Helen Joseph Hospital, Clinical HIV Research Unit, Wits Health Consortium, University of the Witwatersrand, Johannesburg, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nosipho","family":"Ngubane","sequence":"additional","affiliation":[{"name":"King DinuZulu Hospital, Clinical HIV Research Unit, Wits Health Consortium, University of the Witwatersrand, Durban, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ella","family":"Ndlovu","sequence":"additional","affiliation":[{"name":"King DinuZulu Hospital, Clinical HIV Research Unit, Wits Health Consortium, University of the Witwatersrand, Durban, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bern-Thomas","family":"Nyang'wa","sequence":"additional","affiliation":[{"name":"Manson Unit, M\u00e9decins Sans Fronti\u00e8res, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2020,10,10]]},"reference":[{"key":"2025121409445818000_10.10.e036599.1","doi-asserted-by":"publisher","DOI":"10.1007\/s40273-015-0279-6"},{"key":"2025121409445818000_10.10.e036599.2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)31644-1"},{"key":"2025121409445818000_10.10.e036599.3","unstructured":"WHO . Rapid communication: key changes to treatment of multidrug- and rifampicin-resistant tuberculosis (MDR\/RR-TB). 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The end TB strategy. Geneva, Switzerland, 2015."},{"key":"2025121409445818000_10.10.e036599.12","unstructured":"Vassall A , Sweeney S , Kahn JGJ , et al . Reference case for estimating the costs of global health services and interventions. global health cost Consortium, 2017. Available: https:\/\/ghcosting.org\/pages\/standards\/reference_case"},{"key":"2025121409445818000_10.10.e036599.13","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1002\/hec.3304","article-title":"Methodological issues to consider when collecting data to estimate poverty impact in economic evaluations in low-income and middle-income countries","volume":"25(Suppl 1)","author":"Sweeney","year":"2016","journal-title":"Health Econ"},{"key":"2025121409445818000_10.10.e036599.14","unstructured":"The BMJ . Engaging communities in tuberculosis research: the experience of the TB-PRACTECAL trial. Available: https:\/\/blogs.bmj.com\/bmj\/2018\/11\/09\/engaging-communities-tuberculosis-research-experience-practecal-trial\/ [Accessed 16 Dec 2019]."},{"key":"2025121409445818000_10.10.e036599.15","doi-asserted-by":"crossref","unstructured":"Babaniyazov A , Nyang\u2019wa BT , Pardington N . \u2018Trial and Error\u2019 operational reflections on the set-up of a community engagement programme for a phase ii\/iii clinical trial to identify new MDR-TB treatments in Uzbekistan. In: M\u00e9decins sans Fronti\u00e8res scientific day South Asia (not peer reviewed), 2016.","DOI":"10.7490\/f1000research.1112000.1"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2019-036599","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T17:45:05Z","timestamp":1765734305000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2019-036599"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,10]]},"references-count":15,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2020,10,10]]},"published-print":{"date-parts":[[2020,10]]}},"alternative-id":["10.1136\/bmjopen-2019-036599"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2019-036599","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,10]]}}}